The invention relates to a device for stimulating acupuncture points of a body and, more particularly, for stimulating them from the surface of the body with electricity.
Acupuncture is an ancient medical art dating back more than 2000 years. Traditionally, points in the human body (herein called acupuncture points) were reached by piercing the body with fine wires or needles. The needles were then rotated or oscillated about their longitudinal axes, for example by rubbing an exposed end of a needle between a thumb and finger, to stimulate the acupuncture points.
Stimulation of specific acupuncture points has been shown in several studies to have great utility as adjuvant therapy to conventional medical treatments such as nausea and vomiting, postoperative pain, headache, smoking cessation, erectile dysfunction, depression, male fertility, dysmenorrhea, and stomach acid secretion. Great impetus to the use of acupuncture was generated when the National Institutes of Health Consensus Conference on Acupuncture in 1997 showed efficacy of acupuncture in adult postoperative and chemotherapy nausea and vomiting and in postoperative dental pain, and that there were other situations, such as addiction, stroke rehabilitation, headache, menstrual cramps, tennis elbow, fibromyalgia, myofascial pain, osteoarthritis, low back pain, carpal tunnel syndrome, and asthma, in which acupuncture may be useful as an adjunct treatment or an acceptable alternative or be included in a comprehensive management program.
The publications described above and listed below are incorporated herein by reference:
Werntoft,E and Dykes,A, Effect of Acupressure on Nausea and Vomiting During Pregnancy: A Randomized, Placebo-Controlled, Pilot Study. J of Reprod Med, 2001,9:,p835-839
Schlager, A., T. Offer, and I. Baldissera, Laser stimulation of acupuncture point P6 reduces postoperative vomiting in children undergoing strabismus surgery. Br J Anaesth, 1998. 81(4): p. 529-32.
De Aloysio, D. and P. Penacchioni, Morning sickness control in early pregnancy by Neiguan point acupressure. Obstet Gynecol, 1992. 80(5): p. 852-4.
Dundee, J. W., et al., Acupuncture prophylaxis of cancer chemotherapy-induced sickness. J R Soc Med, 1989. 82(5): p. 268-71.
Chen, L., et al., The effect of location of transcutaneous electrical nerve stimulation on postoperative opioid analgesic requirement: acupoint versus nonacupoint stimulation. Anesth Analg, 1998. 87(5): p. 1129-34.
Christensen, P. A., et al., Electroacupuncture and postoperative pain. Br J Anaesth, 1989. 62(3): p. 258-62.
Shen, J et al, Electroacupuncture for Control of Myeloablative Chemotherapy Induced Emesis: A Randomized Controlled Trial, JAMA, 2000, 284(21): p. 2755-2761
Vincent, C. A., A controlled trial of the treatment of migraine by acupuncture. Clin J Pain, 1989. 5(4): p. 305-12.
Waite, N. R. and J. B. Clough, A single-blind, placebo-controlled trial of a simple acupuncture treatment in the cessation of smoking. Br J Gen Pract, 1998. 48(433): p. 1487-90.
Kho, H. G., et al., The use of acupuncture in the treatment of erectile dysfunction. Int J Impot Res, 1999. 11(1): p. 41-6.
Luo, H., et al., Clinical research on the therapeutic effect of the electro-acupuncture treatment in patients with depression. Psychiatry Clin Neurosci, 1998. 52 Suppl: p. S338-40.
Siterman, S., et al., Effect of acupuncture on sperm parameters of males suffering from subfertility related to low sperm quality. Arch Androl, 1997. 39(2): p. 155-61.
Helms, J. M., Acupuncture for the management of primary dysmenorrhea. Obstet Gynecol, 1987. 69(1): p. 51-6.
Tougas, G., et al., Effect of acupuncture on gastric acid secretion in healthy male volunteers. Dig Dis Sci, 1992. 37(10): p. 1576-82.
NIH Consensus Conference. Acupuncture JAMA, 1998. 280(17): p. 1518-24.
Omura, Y., Simple custom-made disposable surface electrode system for non-invasive “electro-acupuncture” or TNS and its clinical applications including treatment of cephalic hypertension and hypotension syndromes as well as temporo-mandibular joint problems, tintinitus, shoulder and lower back pain, etc. Acupunct Electrother Res, 1981. 6(2-3): p. 109-34.
However, many patients resist acupuncture primarily due to a fear of its needling or a contraindication for acupuncture using acupuncture needles (e.g., bleeding disorders, active infection). The needle phobic pediatric patient, in particular, is extremely reluctant. Therefore, electric stimulation of acupuncture points from the skin or surface of a body without invasive needles has been tried. The following patents on electric stimulation inside a human body from the skin or surface of the body at least acupuncture-like without needles and considered to be the references most pertinent to my invention are also incorporated herein by reference.
Kitov U.S. Pat. No. 4,915,110, issued Apr. 10, 1990 describes a device consisting of a center and outer circular electrically conducting material covered by a current insulating material.
The device includes:
1. concentric electrodes with an electrically insulating covering on the outer (annular) electrode.
2. A method for inducing an electrostatic charge between the two electrodes for field stimulation of an acupuncture point.
The device does not include:
1. A self-adhering, electrically conductive device which is flexible and can be positioned anywhere on the body.
2. Surface electrical stimulation to a specific acupuncture point.
Frick U.S. Pat. No. 4,907,601 issued Mar. 13, 1990 describes a device consisting of center electrode surrounded by outer electrodes comprised of gold or gold alloy. Each of the outer electrodes supplied power independently by a switching device with the center electrode being the reference pole.
The device includes:
1. concentric electrodes
2. gold or gold alloy electrodes
3. A switching device that switches between one of the outer electrodes and center electrode in a programmed fashion. In the range of frequencies between 0,5 and 20 Hz.
4. Outer and inner electrodes are of different surface measurements.
The device does not include:
1. A self-adhering device which can be positioned anywhere on the body.
2. A electrically conductive gel or electrically conductive gel/adhesive coupling to Silver/Silver chloride electrode surfaces.
3. A electrically non-conductive adhesive surrounding electrically conductive gel wells to allow for attachment of the device to the skin.
4. A self-contained electrical conductive gel/adhesive to couple the electrical signal between the electrode and the skin surface.
5. An outer annular array functioning as a single electrode in relationship to the center electrode operating between 1 and 500 Hz.
Axelgaard U.S. Pat. No. 5,785,040 (also U.S. Pat. No. 5,450,845) issued Jul. 28, 1998 describes a device consisting of an electrically non-conducting backing material, a flexible electrically conductive patch, a lead wire connected to the electrically conductive portion and a separate gel pad for releasably coupling to the surface of the skin. The gel pad being able to include a drug for iontophoretic delivery.
The device includes:                1) A flexible electrode patch with an attached wire lead and conductive gel pad.        2) A method for providing an array of these electrode patches on a single flexible sheet (backing) which provides compression by use of stretchable straps for electrical stimulation between them.        
The device does not include:                1) a self-adhering device which can be positioned anywhere on the body.        2) concentric electrodes; and        3) provisions for variable frequencies and pulse widths as required for the specific acupuncture point to be stimulated.        
Wilson U.S. Pat. No. 4,398,545, issued on Aug. 16, 1983, illustrates a bandage type device designed to block pain impulses originating from an injury.
From its Abstract:
A bandage to be applied adjacent to an injured portion of a patient's body contains electronic circuitry which delivers electric pulses into the body to block or mask the pain arising from the injury. The bandage includes an inner unit adapted to be applied directly onto the patient's skin and a removable outer unit adapted to be applied upon the inner unit. The inner unit includes spaced apart conductive portions which contact the patient's skin. The outer unit includes a power source and an electronic circuit which applies a voltage output to the conductive portions of the inner unit. The voltage output is transmitted through the conductive portions to the patient's skin to cause low current electrical pulses within the patient's body to block or mask the pain arising from the injury.
The device includes:
1) an inner and outer unit, the inner unit including two flat electrodes with opening for electrolyte (conductive) solution and the outer unit containing electronic circuitry; and
2) two large electrodes patches which are used for skin contact and to direct current flow.
The device does not include:
1) an indication or application for stimulation of acupuncture points; it is designed to be used for muscular pain and is applied directly to the affected area; and
2) concentric electrodes about a center electrode and an outer circumferential electrode, both electrodes using an electrolytic gel, which allows a low resistance connection between the electrode and the skin.
The Bertolluci U.S. Pat. No. 4,981,146 issued on Jan. 1, 1991, illustrates a watch like device designed to alleviate nausea. From its Abstract:
A nausea control device is provided in the form of a watch-like housing and related attachment band for mounting onto the human wrist, wherein the device includes electronic circuitry for imparting electrical impulses via positive and negative electrodes to the pericardium six (P6 a.k.a. MH6) acupuncture point for alleviating nausea. Batteries within the housing power the electric circuitry, and a manually operable switch on the housing controls on/off and pulse amplitude.
The device includes:
1) an inner and outer unit, the inner unit including linear arranged electrodes for a specified frequency (70 Hz) and pulse width (80 ns) and the outer unit containing electronic circuitry;
2) surface stimulation of an acupuncture point; and
3) variable amplitude adjustment.
The device does not include:
1) a self-adhering device which can be positioned anywhere on the body, including many other acupuncture points in addition to MH6.
2) concentric electrodes; and
3) provisions for variable frequencies and pulse widths as required for the specific acupuncture point to be stimulated.
The references cited in the Bertolluci patent include:
the Hoffman U.S. Pat. No. 3,107,672, and the Moss U.S. Pat. No. 3,424,165, which are directed toward stimulating and firming the muscles for cosmetic purposes;
the Oseau U.S. Pat. No. 3,911,910, which teaches devices designed to relieve involuntary muscle spasticity;
the Crossley U.S. Pat. No. 4,715,367, which teaches devices to assist in refraining from undesirable habits by utilizing painful or alarming electrical stimulation; and
the Hathaway U.S. Pat. No. 2,223,447, which illustrates a non-portable radiotherapy system designed for treatment of certain diseases.
None of these are designed for use specific to acupuncture points, none use a concentric arrangement of outer and inner electrode and none are able to be used without assistance.
However, the Omura publication incorporated above describes a disposable flat surface electrode to be constructed by the practitioner out of adhesive tape, aluminum foil and thumb tacks for use in electro-acupuncture. It is similar to the Wilson U.S. Pat. No. 4,398,545 in design and application and, therefore, has the same differences from my invention.
Grey U.S. Pat. No. 6,272,383, which extends the Bertolluci patent ‘wrist band’ type device to two points on the calf (GB-39 and ST-36).
The device does not include:
1) a self-adhering device which can be positioned anywhere on the body, including many other acupuncture points.
2) concentric electrodes; and
3) provisions for variable frequencies and pulse widths as required for the specific acupuncture point to be stimulated.
Garcia-Rill U.S. Pat. No. 5,950,635 relates to treatment of an anxiety disorder with stimulation of 3 acupuncture points (LR-3, HT-3, PC-6) with either acupuncture needles or standard TENS electrodes at a specified frequency (5 Hz).
The device does not include:
1) a self-adhering device which can be positioned anywhere on the body.
2) concentric electrodes; and
3) provisions for variable frequencies and pulse widths as required for the specific acupuncture point to be stimulated.
Cazaux U.S. Pat. No. 5,957,951 relates to a wrist-watch type device with multiple contact points arranged in a linear array of three rows and three columns connected to a stimulator (pulse generator) which provides stimulation to one or more points on the wrist underlying the contact points to treat various conditions.
The device does not include:
1) a self-adhering device which can be positioned anywhere on the body, including many other acupuncture points.
2) concentric electrodes.